Warfarin Sodium

Product NDC
64725-0833
11-digit product format
647250833
Labeler code
64725
Product ID
64725-0833_42473c39-b5b9-429c-a21f-8c63cbb65310
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA040145
Marketing category
ANDA
Marketing start
1997-07-25
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
5 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64725-0833IInactivated by FDA2026-10-05
excluded packagepackage64725-083364725-0833-1IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64725-0833-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64725-0833-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64725-0833-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64725-0833-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64725-0833-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64725-0833-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64725-0833-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64725-0833-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64725-0833-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64725-0833-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64725-0833-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64725-0833-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64725-0833-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64725-0833-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64725-0833-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64725-0833-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64725-0833-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64725-0833-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64725-0833-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64725-0833-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64725-0833-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage64725-0833-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040145-001WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORAL1997-03-26
A040145-002WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORAL1997-03-26
A040145-003WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORAL1997-03-26
A040145-004WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORAL1997-03-26
A040145-005WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORAL1997-03-26
A040145-006WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORAL1997-03-26
A040145-007WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORAL1997-03-26
A040145-008WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORAL1998-11-05
A040145-009WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORAL1998-11-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 10 · 387 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040145-001WARFARIN SODIUM1MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-002WARFARIN SODIUM2MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-003WARFARIN SODIUM2.5MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-004WARFARIN SODIUM4MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-005WARFARIN SODIUM5MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-006WARFARIN SODIUM7.5MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-007WARFARIN SODIUM10MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-008WARFARIN SODIUM3MGTABLET / ORAL1998-11-0584e616aacf4f…
2026-09-14 22:38:342026-08A040145-009WARFARIN SODIUM6MGTABLET / ORAL1998-11-0584e616aacf4f…
2026-08-18 06:07:402026-07A040145-001WARFARIN SODIUM1MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-002WARFARIN SODIUM2MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-003WARFARIN SODIUM2.5MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-004WARFARIN SODIUM4MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-005WARFARIN SODIUM5MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-006WARFARIN SODIUM7.5MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-007WARFARIN SODIUM10MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-008WARFARIN SODIUM3MGTABLET / ORAL1998-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-009WARFARIN SODIUM6MGTABLET / ORAL1998-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040145-001WARFARIN SODIUM1MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-002WARFARIN SODIUM2MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-003WARFARIN SODIUM2.5MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-004WARFARIN SODIUM4MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-005WARFARIN SODIUM5MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-006WARFARIN SODIUM7.5MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-007WARFARIN SODIUM10MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-008WARFARIN SODIUM3MGTABLET / ORAL1998-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-009WARFARIN SODIUM6MGTABLET / ORAL1998-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-001WARFARIN SODIUM1MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-002WARFARIN SODIUM2MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-003WARFARIN SODIUM2.5MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-004WARFARIN SODIUM4MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-005WARFARIN SODIUM5MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-006WARFARIN SODIUM7.5MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-007WARFARIN SODIUM10MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-008WARFARIN SODIUM3MGTABLET / ORAL1998-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-009WARFARIN SODIUM6MGTABLET / ORAL1998-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040145-001WARFARIN SODIUM1MGTABLET / ORAL1997-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040145-002WARFARIN SODIUM2MGTABLET / ORAL1997-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040145-003WARFARIN SODIUM2.5MGTABLET / ORAL1997-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040145-004WARFARIN SODIUM4MGTABLET / ORAL1997-03-266a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-006AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-007AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-008AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-009AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040145-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-006AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-007AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-008AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-009AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-006AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-007AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-008AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-009AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040145-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-006AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-007AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-008AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-009AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040145-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040145-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040145-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040145-004AB14b0b4de00fa7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
abcfe2f4-1eca-fdc3-341b-b8134a1aec1fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0833-1Warfarin Sodium100 in 1 BOTTLETABLET1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [TYA PHARMACEUTICALS]2
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [TYA PHARMACEUTICALS]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [TYA PHARMACEUTICALS]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [TYA PHARMACEUTICALS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WARFARIN SODIUM TABLET [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUWARFARIN SODIUM TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0833WARFARIN SODIUM TABLET [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141027_ed1d5b87-84d2-4ec7-b1bc-cf8f5096e938.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855332warfarin sodium 5 MG Oral TabletPSNed1d5b87-84d2-4ec7-b1bc-cf8f5096e9382
855332warfarin sodium 5 MG Oral TabletSCDed1d5b87-84d2-4ec7-b1bc-cf8f5096e9382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0833-164725083301100 in 1 BOTTLEHistorical